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PICSO in Patients With STEMI Treated by Primary Percutaneous Coronary Intervention (pRAMSES)

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ClinicalTrials.gov Identifier: NCT01493037
Recruitment Status : Completed
First Posted : December 15, 2011
Last Update Posted : July 16, 2014
Sponsor:
Information provided by (Responsible Party):
Miracor Medical SA

Tracking Information
First Submitted Date  ICMJE December 13, 2011
First Posted Date  ICMJE December 15, 2011
Last Update Posted Date July 16, 2014
Study Start Date  ICMJE December 2011
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 14, 2011)
Successful delivery of PICSO treatment [ Time Frame: 90 minutes ]
Assessment of the feasibiity of PICSO in STEMI patients defined as the successful elivery of the PICSO catheter and the successful administration of PICSO treatment for 90 minutes
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 14, 2011)
  • MRI measurement of infarct size [ Time Frame: 4 months ]
    Infarct size assessed by cardiac MRI between 2-5 days post primary PCI and again at 120 days follow up
  • Assessment of left ventricular function [ Time Frame: 4 months ]
    Left ventricular function assessed by echocardiography between 2-5 days after primary PCI and at 120 days
  • Assessment of microvascular perfusion [ Time Frame: 4 months ]
    Microvascular perfusion assessed by cardiac MRI between 2-5 days after primary PCI and at 120 days
  • Resolution of ST-segment elevation [ Time Frame: 24 hours ]
    Occurrence of complete resolution of ST-segment elevation 30, 60, 90 and 120 minutes after last contrast injection prior to PICSO placement procedure on 24 hour continuous 12 lead ECG Holter monitor recording
  • Measurement of ST segment time curve area [ Time Frame: 3 hours ]
    ST segment time curve area for the first 3 hours on 24 hour continuous 12 lead ECG Holter monitor recording.
  • Number of adverse events [ Time Frame: 6 months ]
    Safety endpoints recorded are Major Adverse Cardiac Events (MACE), Major Adverse Cardiac and Cerebrovascular Events (MACCE), net adverse clinical events (MACE and bleeding), Serious and non serious Adverse Device Events ((S)ADE) rates
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PICSO in Patients With STEMI Treated by Primary Percutaneous Coronary Intervention
Official Title  ICMJE Pressure Controlled Intermittent Coronary Sinus Occlusion in Patients With ST Segment Elevation Myocardial Infarction Treated by Primary Percutaneous Coronary Intervention: Safety and Feasibility Study
Brief Summary A prospective multi-center study in which patients with an acute heart attack (in the left anterior descending artery) with ECG changes (ST segment elevation) receive angioplasty followed by stent placement and 90 minutes of PICSO treatment. This is a proof of concept study designed to document the safety and feasibility of the Pressure Controlled Intermittent Coronary Sinus Occlusion (PICSO) Impulse system.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE ST Elevation (STEMI) Myocardial Infarction
Intervention  ICMJE Device: PICSO (Pressure-controlled Intermittent Coronary Occlusion
The PICSO catheter has a balloon which is placed in the coronary sinus via the femoral vein. The balloon is inflated and deflated at intervals calculated by an algorithm and adjusted according to the patient's own coronary sinus pressure plateau.
Other Names:
  • PICSO Impulse Catheter
  • PICSO Impulse Console
Study Arms  ICMJE PICSO
PICSO treatment for 90 minutes
Intervention: Device: PICSO (Pressure-controlled Intermittent Coronary Occlusion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 15, 2014)
30
Original Estimated Enrollment  ICMJE
 (submitted: December 14, 2011)
40
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • First time anterior STEMI defined by the following:

    • Symptoms of myocardial ischemia > 30 minutes and < 12 hours
    • ST-segment elevation > 1mm (> 0.1 mV) in two contiguous precordial leads in the anterior territory on a 12-lead ECG
  • Uncomplicated PCI of a LAD culprit lesion (defined as angioplasty followed by stent placement or direct stenting without the occurrence of an adverse event(s) that would preclude further study participation, such as major bleeding, perforation, hypotension, pulmonary edema or instability that in the judgement of the investigator preclude participation in the trial)

Exclusion Criteria:

  • Younger than 18 years of age
  • Hospitalization with a primary diagnosis of acute myocardial infarction (AMI) previously or has evidence of previous Q-wave infarct
  • Left main coronary artery culprit lesion
  • Additional stenosis in the LAD for which PCI or CABG is likely to be needed in the next 6 months and which is not treated during the index procedure
  • Cardiogenic shock (systolic blood pressure ≤90 mmHg in spite of conservative measures) or pulmonary edema (O2 saturation <90% by pulse oximetry and the presence of rales or crackles)
  • Cardiac arrest requiring chest compression or resuscitation
  • Anatomical complications limit capacity to place PICSO Impulse device or achieve stable catheter placement or occlude coronary sinus
  • Known renal disease (GFR < 30 mL/min/1.73m2) or dialysis
  • History of stroke, TIA or reversible ischemic neurological disease within last 6 months
  • Left bundle branch block
  • Known contra-indication for magnetic resonance imaging (Metallic implant precluding MRI, claustrophobia, obesity precluding MRI, etc.)
  • Presence of any lead in the coronary sinus
  • Active or treated malignancies in the last 12 months
  • Previous coronary artery bypass graft surgery
  • Known severe anemia (Hgb < 10 g/dL or < 6.2 mmol/L)
  • Known platelet count < 100,000, known coagulopathy or bleeding diathesis, or unwilling to accept transfusions
  • Participation in another ongoing clinical study
  • Women of child-bearing age
  • Non-cardiac comorbidities and life expectancy < 1 year
  • Legal incompetence
  • A condition that, in the opinion of the Investigator, precludes participation, including compliance with all follow-up procedures
  • No dependents neither to the sponsor nor to the investigator
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01493037
Other Study ID Numbers  ICMJE CIP 2011-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Miracor Medical SA
Study Sponsor  ICMJE Miracor Medical SA
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jan J Piek, Professor Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
PRS Account Miracor Medical SA
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP